MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYSTEM ACCESSORY; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	8815
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood on the device was observed.The tortous target lesion was located in the left anterior descending artery, left circumflex artery, and right coronary artery.A sled system accessory was selected for use.However, when the physician unpacked the device there was blood on it.The sterility of the device was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that blood on the device was observed.The tortous target lesion was located in the left anterior descending artery, left circumflex artery, and right coronary artery.A sled system accessory was selected for use.However, when the physician unpacked the device there was blood on it.The sterility of the device was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the sled was returned in overall good physical condition.It was returned with no traces of blood on the outer surfaces.The lot number sticker was missing.The sled could properly connect to the motor drive unit 5 plus.During functional testing using a test catheter, the sled could properly pull back and performed within specifications.The sled could be manually pulled back with the mdu5+ in place.No disconnect error message.No issue going between automatic and manual pullback.Mdu5+ was picked up by handle and also shaken holding the handle, both resulting in no disconnect error message.Sled lay flat on table with no movement or shaking.There were no issues with the returned sled.

• Brand Name: SYSTEM ACCESSORY
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10214104
• Report Number: 2134265-2020-08669
• Device Sequence Number: 2133922
• Product Code: DQK
• UDI-Device Identifier: 08714729228684
• UDI-Public: 08714729228684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Device Lot Number: S1005377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 65